Comparison of NN1250 With Sitagliptin in Subjects With Type 2 Diabetes Never Treated With Insulin
Summary
This trial will be conducted in Africa, Asia, North America and South America. The aim of this clinical trial is to compare NN1250 with sitagliptin, as add-on to subject's own current oral antidiabetic (OAD) treatment, in subjects with type 2 diabetes inadequately controlled with 1-2 OADs (metformin, sulphonylurea, glinides or pioglitazone).
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Diabetes Mellitus, Type 2
Intervention
NN1250, sitagliptin
Location
Novo Nordisk Clinical Trial Call Center
Huntsville
Alabama
United States
35801
Status
Active, not recruiting
Source
Novo Nordisk
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01046110
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Diabetes Mellitus, Type 2
A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.
Prediabetic State
The time period before the development of symptomatic diabetes. For example, certain risk factors can be observed in subjects who subsequently develop INSULIN RESISTANCE as in type 2 diabetes (DIABETES MELLITUS, TYPE 2).
Diabetes Mellitus, Type 1
A subtype of DIABETES MELLITUS that is characterized by INSULIN deficiency. It is manifested by the sudden onset of severe HYPERGLYCEMIA, rapid progression to DIABETIC KETOACIDOSIS, and DEATH unless treated with insulin. The disease may occur at any age, but is most common in childhood or adolescence.
Diabetes Mellitus, Lipoatrophic
A type of diabetes mellitus that is characterized by severe INSULIN RESISTANCE and LIPODYSTROPHY. The latter may be generalized, partial, acquired, or congenital (LIPODYSTROPHY, CONGENITAL GENERALIZED).
Diabetic Ketoacidosis
A life-threatening complication of diabetes mellitus, primarily of TYPE 1 DIABETES MELLITUS with severe INSULIN deficiency and extreme HYPERGLYCEMIA. It is characterized by excessive LIPOLYSIS, oxidation of FATTY ACIDS, production of KETONE BODIES, a sweet smell to the breath (KETOSIS;) DEHYDRATION; and depressed consciousness leading to COMA.
Clinical Trials
Comparison of Two NN1250 Formulations in Subjects With Type 1 Diabetes
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic properties (effect) by comparing two NN1250 formulations in subjects with type 1 diabetes.
Comparison of NN1250 With Insulin Glargine in Type 1 Diabetes
This trial is conducted in Europe and in the United States of America (USA). The aim of the trial is to investigate the efficacy and safety of NN1250 in subjects with type 1 diabetes.
Sitagliptin Mechanism of Action Study in Patients With Type 2 Diabetes Mellitus
A clinical study to determine the safety, efficacy and the way sitagliptin works in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control.
A Trial Investigating the Within-subject Variability of NN1250 in Subjects With Type 1 Diabetes
This trial is conducted in Europe. The aim of this clinical trial is to evaluate the variability in the blood glucose-lowering effect of NN1250 in subjects with type 1 diabetes.
Sitagliptin Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus
A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control on metformin therapy.
PubMed Articles
The efficacy and safety of taspoglutide, a long-acting human glucagon-like peptide-1 analog, were compared with sitagliptin or placebo, as adjunct to metformin, in patients with inadequately controlle...
Purpose The case of a patient with type 2 diabetes mellitus who received combination exenatide-sitagliptin with glipizide is reported. Summary A 55-year-old, 204-lb Caucasian woman arrived at a clinic...
Sitagliptin or exenatide once weekly for type 2 diabetes: comparison of the clinical trials.
Introduction: There is a need for new and improved treatments for type 2 diabetes. Glucagon-like peptide 1 (GLP-1) is a gut hormone that stimulates insulin secretion and the levels of GLP-1 can be inc...
BACKGROUND: Dipeptidyl peptidase-4 inhibitors improve glycaemic control in patients with type 2 diabetes mellitus when used as monotherapy or in combination with other anti-diabetic drugs (metformin,...
Pharmacokinetic and pharmacodynamic evaluation of sitagliptin plus metformin.
Importance of the field: Type 2 diabetes is an increasingly prevalent disease resulting from various complex combinations of defects in insulin secretion and insulin action. Adequate blood glucose con...
